Recently, Xinhua Pharmaceutical's sevelamer carbonate dry suspension (specifications: 0.8g; 2.4g ) received the Drug Registration Certificate issued by the National Medical Products Administration. The approval of this dosage form provides a new treatment option for patients with hyperphosphatemia due to chronic kidney disease ( CKD ).
Hyperphosphatemia is a common complication in maintenance hemodialysis ( MHD ) patients and a challenge in their treatment. Studies show that almost all end-stage chronic kidney disease (CKD) patients have hyperphosphatemia, which is associated with adverse clinical outcomes. Therefore, it is recommended that CKD patients receive phosphorus-lowering therapy to achieve normal serum phosphorus levels.
Sevelamer is a calcium-free, non-metallic phosphate binder. Its mechanism of action is to bind with phosphorus in the gastrointestinal tract, thereby reducing its absorption. Compared with metal-containing preparations such as calcium carbonate, it effectively avoids the risks of elevated blood calcium and metal accumulation. Sevelamer carbonate dry suspension is clinically used to control hyperphosphatemia in adult patients with chronic kidney disease (CKD) undergoing dialysis, and to control hyperphosphatemia in adult CKD patients with serum phosphorus ≥1.78 mmol/L who are not undergoing dialysis. This product is a Category B drug in the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2025 Edition). According to relevant statistics, the sales of sevelamer-related preparations in Chinese public medical institutions in 2025 were approximately RMB 750 million.
Previously, the company's sevelamer carbonate tablets had been approved for marketing. The launch of sevelamer carbonate dry suspension will create a dual-dosage supply with sevelamer carbonate tablets, further meeting the medication needs of different patient groups.

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